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CQV (Commissioning, Qualification, and Validation) Engineer
3 months ago
Engineer I, CQV, Laboratory Compliance, Clinical Biomarker Laboratory
6 Month Contract
100% Onsite in Norwood, MA
*W2 ONLY NO C2C OR 3rd Party*
Pay Rate: $50PH
MUST HAVE:
- Experience in GCLP/GLP or CLIA/CAP environment.
- Experience with the qualification of Lab equipment & Lab instruments
- Will be managing a large amount of paperwork through the system and driving the qualification process
Summary
The Engineer I, CQV (Commissioning, Qualification, and Validation) will be responsible for delivering commissioning, qualification, and validation activities ensuring equipment and systems remain in a qualified operational state of compliance within a GCLP/GLP Laboratory environment. This individual will collaborate closely with Lab Operations, Lab Compliance and R&D Quality to complete qualification activities. The ideal candidate enjoys working in a fast-paced, dynamic, and innovative environment.
Responsibilities
- Execute commissioning, qualification, and validation activities to maintain compliance with GCLP guidelines and GLP regulations.
- Author and execute design, commissioning, qualification, and validation documentation and support records to certify compliance with specifications and procedures.
- Ensure timely resolution of documentation compliance and quality system issues.
- Investigate deviations related to qualification and validation activities
- Participate in cross-functional teams to meet project timelines and business needs while adhering to regulatory requirements.
- Ensure Standard Operating Procedures (SOPs) and procedures are created, understood, and followed.
- Participate in XXX training to support CQV requirements.
Education & Qualifications
- B.S. in engineering, science, or an equivalent technical field.
- Minimum of one (1) year of relevant experience in a GCLP/GLP environment is desirable.
- Understanding of commissioning, qualification, and validation principles.
- Strong technical documentation generation and review skills, ensuring content is technically sound and adheres to applicable site procedures.
- Ability to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions.
- Excellent interpersonal and communication skills (verbal and written), with the ability to present work to peers and cross-functional managers and influence leadership decisions.
- Ability to interact well with other groups and take ownership of and follow through on assignments.
- Ability to represent the company's interests, objectives, and policies in a professional and responsible manner.
- Meticulous attention to detail, organizational ability, clinical judgment, and good communication skills.
- High proficiency in MS PowerPoint and MS Project, excellent writing skills, organizational skills, and attention to detail.
- A desire to make an impact as part of a high-growth, transformational company
